Director, Combination Product & Device Development
Listed on 2026-02-19
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Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry, Product Engineer
About Jade Biosciences
Jade Biosciences is a clinical‑stage biotechnology company focused on developing best‑in‑class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE
101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE
201, an afucosylated anti‑BAFF‑R monoclonal antibody, as well as JADE
301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit and follow the Company on Linked In.
We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including prefilled syringes, autoinjectors and other drug‑device combination products.
The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.
Key Responsibilities Device Development- Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
- Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
- Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
- Drive design control documentation, risk assessments, usability studies, and human factors integration.
- Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
- Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
- Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
- Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
- Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
- Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
- Oversee development of statistically sound verification protocols, reports, and design validation strategies.
- Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.
- Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
- Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
- Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
- Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
- Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.
- Ensure compliance with global combination product and medical device regulations,…
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